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A Prospective, Multicenter, Phase II Clinical Study on the Treatment of Unresectable Advanced HCC with DEB-TACE Combined with SALOX-HAIC

ConditionHepatocellular Carcinoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorXuhua Duan

About this trial

The aim of this study is to clarify the safety and efficacy of DEB-TACE combined with SALOX-HAIC in the treatment of unresectable advanced primary liver cancer. To determine whether this therapy can prolong the indicators such as PFS, TTP, OS, ORR, and DOR.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Patient with unresectable HCC who strictly meet the clinical diagnostic criteria of the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 Edition) or who have been confirmed by histopathology or cytology, There was at least one measurable lesion (according to the requirements of mRECIST 1.1, the spiral CT scan diameter of the measurable lesion was ≥10mm or the short diameter of enlarged lymph node was ≥15mm).

Disqualifiers

1. Imaging examinations were conducted for HCC patients with large liver tumors (≥60% of liver volume), or carcinoma thrombus in main portal vein (occupying ≥50% of vascular diameter), or carcinoma thrombus invading mesenteric vein or inferior vena cava, or significant arteriovenous/venous fistula.

Trial population

unresectable advanced HCC

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

59 Participants
are grouped into 1 trial group
Group A: DEB-TACE+ SALOX-HAIC+Apatinib+Carilizumab

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

Time frame
Time from the first DEB-TACE treatment to either radiological progression or death or up to 24 months

Secondary outcomes

1

Overall survival (OS)

Time frame
Time Frame: Time from the first DEB-TACE treatment to death or up to 24 months
2

Objective response rate (ORR)

Time frame
1, 3, 6,12,18,24 months after the first DEB-TACE treatment, up to death or 24 months, whichever came first.
3

Disease control rate (DCR)

Time frame
1, 3, 6,12,18,24 months after the first DEB-TACE treatment, up to death or 24 months, whichever came first
4

Time to Progression (TTP)

Time frame
Time from the first DEB-BACE treatment to either radiological progression up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xuhua Duan

Lead sponsor

The First Affiliated Hospital of Zhengzhou University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: